FDA 510(k) Application Details - K143592

Device Classification Name Bacteriophage And Controls, B. Anthracis Lysis

  More FDA Info for this Device
510(K) Number K143592
Device Name Bacteriophage And Controls, B. Anthracis Lysis
Applicant THE SURGEON GENERAL, DEPARTMENT OF THE ARMY
1430 VETERANS DRIVE
FORT DETRICK, MD 21702-5009 US
Other 510(k) Applications for this Company
Contact Kenneth A. Bertram
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code NVQ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/18/2014
Decision Date 04/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact